Arthrex® AR-7220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867041486), received between Feb 15, 2019 and May 23, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH EMAIL THAT AN AR-7220 FIBERWIRE NEEDLE BROKE OFF IN THE WIRE DURING SURGERY. SURGEON WAS ABLE TO RETRIEVE ALL BROKEN PARTS. THIS WAS DISCOVERED DURING A PERONEUS BREVIS TENDON REPAIR OF THE FOOT ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469520 ↗
• MalfunctionMay 3, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-7220 FIBERWIRE AND NEEDLE BROKE INSIDE THE PATIENT. THE FACILITY REPRESENTATIVE DID NOT KNOW HOW THIS OCCURRED BUT STATED THE BROKEN FRAGMENTS REMAIN IN THE PATIENT. THIS WAS DISCOVERED DURING AN AMPUTATION PROCEDURE ON (B)(6) 2022. FACILITY REPRESENTATIVE ALSO DOES NOT KNOW HOW THE CASE WAS COMPLETED BUT THAT IT WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14269352 ↗
• InjuryFeb 15, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A PATIENT HAD AN INITIAL KNUCKLE REPLACEMENT PROCEDURE ON (B)(6) 2018, THEY IMMEDIATELY STARTED EXPERIENCING AN ADVERSE REACTION. THE PATIENT IS HIGHLY SENSITIVE TO NICKLE. NO ARTHREX PARTS WERE IMPLANTED DURING THE FIRST PROCEDURE. ON (B)(6) 2019 THE PATIENT HAD A HARDWARE REMOVAL, AND THE SURGEON IMPLANTED AN ARTHREX FIBERWIRE TO HEAL THE ORIGINAL BONE FRACTURE. AFTER THE REVISION PROCEDURE, THE PATIENT IS STILL EXPERIENCING PAIN AND DISCOMFORT. THE FINGER IS SWOLLEN AND INFLAMED, AND THERE IS SOME DISCOLORATION WITH VERY LITTLE RANGE OF MOTION OF THE FINGER. X-RAYS HAVE BEEN TAKEN, AND THE PATIENT HAS A WEEKLY FOLLOW-UP VISIT WITH THEIR SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 1/23/2019: THE FACILITY CONFIRMED THAT THE ORIGINAL AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON. DURING THE INITIAL PROCEDURE THAT TOOK PLACE ON (B)(6) 2018 A COMPETITOR'S DENTALWIRE WAS IMPLANTED. SOON AFTER HAVING THE DENTALWIRE IMPLANTED, THE PATIENT WAS EXPERIENCING SWELLING, PAIN AND DISCOMFORT AROUND THE SURGICAL SITE. A REVISION PROCEDURE WAS SCHEDULED TO REMOVE THE DENTALWIRE. DURING THE REVISION PROCEDURE, AR-72

  Patient problems: Discomfort; Inflammation; Loss of Range of Motion; Pain; Skin Discoloration; Swelling

  MAUDE report 8344314 ↗